Cayenne Medical has reported that a new independent clinical study published in the February 2010 issue of Orthopedics shows that its AperFix System provides a safe, efficient and secure means of arthroscopic reconstruction of the posterior cruciate ligament (PCL) due to traumatic injury.
The AperFix System is a femoral and tibial fixation device originally designed for soft tissue anterior cruciate ligament (ACL) reconstruction. AperFix is expected to restore native knee kinematics through a simple, single incision, ‘all-inside’ technique that allows the implant to be inserted transtibially, or anteromedially, through a single-tunnel, and eliminates the need to drill through the femoral cortex.
According to the study, six active PCL injury patients underwent PCL reconstruction surgery using the AperFix System. At six months, all patients achieved restored knee stability and full, symmetric range of motion, allowing them to return to their previous level of activity. Full recovery following PCL reconstruction surgery typically requires six to 12 months.
The study authors concluded that the AperFix System’s single-incision all-inside femoral fixation technique efficiently performs arthroscopic soft tissue PCL reconstruction. Authors cited benefits compared to traditional methods, which include reduced bone and soft tissue injury, eliminated need for patient repositioning during surgery and a simplified passage of the allograft through the posterior aspect of the tibia.
Cayenne said the AperFix System has received market clearance from the FDA for soft tissue ACL reconstruction in 2007. In March 2009, AperFix Femoral and Tibial Implants received 510K clearance for extended indications, including a wide variety of tenodesis procedures such as PCL, MCL, LCL and MPFL reconstruction. AperFix implants are made of polyetheretherketone (PEEK) and provide surgeons with aperture fixation, superior pullout strength and active, circumferential tendon compression.
James Hart, president and CEO of Cayenne Medical, said: “PCL reconstruction with the AperFix System is designed to alleviate the challenges some surgeons may experience with conventional BTB (bone-tendon-bone) allografts or soft tissue grafts utilizing cortical fixation techniques. This study not only highlights the flexibility of the system as a solution for multiple ligament reconstructions, it also shows the novel procedure provides superior fixation and knee stability for patients and ease-of-use for surgeons due to aperture fixation.”